It’s always great to start the week off with some good news. Today we learned that the Food and Drug Administration (FDA) has given Asterias Biotherapeutics approval to expand the number and type of people with spinal cord injuries that it treats in their CIRM-funded clinical trial.

Up till now, Asterias has been treating people who have injuries at the C5-C7 level, those are the lowest levels of the cervical spine, near the base of the neck. Now they will be able to treat people with injuries at the C4 level, that’s not only higher up the neck but it’s also the second most common form of spinal cord injury.

In a news release Dr. Ed Wirth, Asterias’ Chief Medical Officer, says this is a vote of confidence from the FDA in the company’s AST-OPC1 stem cell therapy:

“FDA’s decision to allow the company to enroll qualified patients with C-4 level injuries is the result of the data supporting the safety of both AST-OPC1 and the procedure to inject the cells and means that the second most common cervical spinal cord injury population can now be eligible to receive AST-OPC1. The overall changes to the study protocol will enhance our ability to enroll qualified patient candidates for our current SCiStar study and we also expect the changes to help enrollment rates in a future, larger clinical study.”

Photo courtesy Shepherd Center, Atlanta

People who are injured at the C4 level are typically paralyzed from the neck down and need constant help, while people with C5-C7 injuries typically have some use of their hands and arms. Caring for someone with a C4 injury is expensive, with lifetime costs estimated around $5 million. Anything that could help people recover some movement would not only reduce those costs but would, more importantly, also increase the quality of life for people.

Asterias is not only expanding the patient population they are working with, they are also expanding the window for treating the injury. Currently patients have to be enrolled from 14 to 30 days post injury. In this new C4 group that window has been extended to 21 to 42 days post injury.

The reason for that change is that because C4 is higher up in the neck, newly injured people often need to be placed on a ventilator to help stabilize them. These patients take a little more time to recover from the initial trauma before they are ready to be treated.

We have blogged several times (here, here and here) about the encouraging news from the Asterias trial and how it appears to be helping people with injuries at the C5-C7 level recover some movement in their arms and hands. In some cases, such as with Kris Boesen for example, the improvement has been quite dramatic. Now the hope is that this new patient population will see similar benefits.

Kris Boesen, CIRM spinal cord injury clinical trial patient.

The study is being conducted at six centers in the U.S., including some here in California, and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment.

Hello,
My 28 yo daughter has a C5 incomplete SCI that occurred on 6/16/17, she is going to be released from inpatient rehab in approximately 2 weeks. We would be very thankful to obtain information to participate in this study. We live in Temecula, CA
Thank you,
Pete Magnuso

Dear Pete, thank you for reaching out. We’re very sorry to hear about your daughter’s injury. It must be difficult on the entire family. Visit this webpage for more details about the trial: http://www.scistar-study.com/ Based on the information provided on that page, it appears your daughter would not be eligible for this trial because the treatment must be administered at a single point in time between 21 and 42 days after injury. To find other clinical trials, visit http://www.clinicaltrials.gov and review your search results with your daughter’s physician. Also, for general information about stem cell-based clinical trials, we recommend this site: http://www.closerlookatstemcells.org/ Best wishes, CIRM

Hi Darlene. We are sorry to hear about your chronic spinal cord injury. The Asterias trial is specifically treating patients with recent spinal cord injuries. The therapy will be tested for safety and whether it improves movement in patients. If it does, then in the future, similar stem cell-based treatments will hopefully be developed for chronic spinal injuries. You can search for trials for your condition on clinicaltrials.gov.

Dear Judy, I am sorry to hear about your son. I can only imagine how challenging that must make life for him and the whole family. We are funding a clinical trial targeting spinal cord injury but it is only for people with more recent injuries, in the last 40 days, and so I am afraid your son would not be eligible to be part of that research. Looking through other spinal cord injury clinical trials I didn’t find any that might be appropriate for your son or that he would be eligible to be part of.

I am sorry I cannot offer you anything more positive right now, but we are funding research that we hope will, in time, lead to treatments for people with older injuries, such as your son.

Hello, My name is Jessie Palacios and i am a 24 year old quadriplegic with a severe c1 c2 spinal injury. I have very minimal movement. i can balance my head with difficulties, move my left hand to enough where i can use a mouse with screen keyboard with difficulties, i have very little trunk movement, i can move my left leg with difficulties. Very minor movements on my right arm/leg. I have trouble using my hands (fingers). I am interested in any stem cell research program you can offer to me. A respond would be much appreciated, thank you!.

Hi my son has been recently shot this year July 12, 2018 he’s at a t10 spinal cord injury he’s paralyzed from waist down pls help us if you know of any clinical research trial for spinal cord injury my email is gladysmac68@yahoo.com we are willing to travel. My son is only 27 he didn’t deserve this he a good person it’s hard for him to deal with this. We pray every day and night for him to Walk again